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A new material for prevention of peritendinous fibrotic adhesions after tendon repair: oxidised regenerated cellulose (Interceed), an absorbable adhesion barrier.

ABSTRACT: In this experimental study, we aimed to examine the ability of absorbable oxidised regenerated cellulose (Interceed, TC-7, Johnson & Johnson, USA) to inhibit the formation of peritendinous fibrotic adhesions after tendon repair in rats. Both Achilles tendons of 23 female Wistar-Albino rats weighing between 350 and 450 grams were cut and repaired. On the right side, Interceed absorbable adhesion barriers were wrapped around the repaired tendon (group I). On the left, the same procedures were applied except for the Interceed wrapping and these were grouped as control (group II). Animals were sacrificed at postoperative day 28 and macroscopic and histological examination was performed. All the animals survived and no tendon rupture was observed. No wound dehiscence, wound infection or exposure of repaired tendons occurred. Macroscopically, there were three (13.1%) tendons without adhesion formation and 20 (86.9%) tendons with inferior adhesion formation in group I; on the other hand, there were 16 tendons (69.5%) with medium grade adhesion formation and seven tendons (30.5%) with severe peritendinous adhesion formation in group II (control group) (p<0.05). Histologically, adhesion formation was absent in 11 tendons (47.8%) and slight in 12 tendons (52.2%) in group I; while in group II, it was slight in two (8.6%), moderate in 15 (65.2%) and severe in six tendons (26.2%) (p<0.05). Sixteen (69.5%) of 23 tendons in group I and 11 (47.8%) of 23 tendons in group II showed no inflammatory reaction (p<0.05). Nineteen (82.6%) tendons in group I and only one tendon in group II showed excellent to good tendon healing (p=0.00). According to our results, we feel that Interceed may have an intraoperative role to play in the reduction of adhesions after surgical tendon repair. This study suggests that absorbable oxidised regenerated cellulose merits further evaluation as a potential treatment to inhibit the formation of peritendinous adhesions. Rigorous and extensive controlled trials should be undertaken on patients undergoing tendon repair with or without this barrier.

SUBMITTER: Temiz A

PROVIDER: S-EPMC2323407 | biostudies-other | 2008 Jun

REPOSITORIES: biostudies-other

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Project description:Adhesions develop in over 90% of patients after intra-abdominal surgery. Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions. Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery. This agent has limitations through poor handling characteristics because it is sticky on both sides. C-Qur™ Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics. The objective of this study is to assess efficacy and safety of C-Qur™ Film to decrease the incidence of adhesions after colorectal surgery.This is a prospective, investigator initiated, randomized, double-blinded, multicenter trial. Eligible patients undergoing colorectal resection requiring temporary loop ileostomy or loop/split colostomy by laparotomy or hand assisted laparoscopy will be included in the trial. Before closure, patients are randomized 1:1 to either the treatment arm (C-Qur™ Film) or control arm (no adhesion barrier). Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy. During ostomy takedown, adhesions will be evaluated for incidence, extent, and severity. The primary outcome evaluation will be assessment of adhesions to the incision site. It is hypothesized that the use of C-Qur™ Film underneath the primary incision reduces the incidence of adhesion at the incision by 30%. To demonstrate 30% reduction in the incidence of adhesions, a sample size of 84 patients (32 + 10 per group (25% drop out)) is required (two-sided test, ? = 0.05, 80% power).Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic 'hand-assisted' colorectal surgery. We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction, secondary infertility and adhesiolysis related complications are considered multifactorial and difficult to interpret. Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention, since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished.ClinicalTrials.gov Identifier NCT01872650, registration date 6 June 2013.

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A new material for prevention of peritendinous fibrotic adhesions after tendon repair: oxidised regenerated cellulose (Interceed), an absorbable adhesion barrier.

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